NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia (NCT06706414) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia
Denmark16 participantsStarted 2025-03-01
Plain-language summary
This clinical interventional study aims to assess whether treatment with denosumab in combination with letrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker.
Who can participate
Age range18 Years – 60 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infertile men ≥ 18 years and \< 60 years of age with azoospermia with normal semen volume (\> 0.9 mL) verified by minimum 2 semen samples.
* No identifiable cause of obstruction.
* Testis size (Prader Orchidometer) ≤ 15 mL on both sides in patients where no prior TESE is available
* Serum AMH levels ≥5 pmol/L.
Exclusion Criteria:
* Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc.
* Chromosome anomalies e.g. Klinefelter Syndrome, XX male
* AZFa/b/c microdeletions besides b2/b3 og gr/gr
* Detected CFTR mutation
* Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded
* Men with hypocalcemia at baseline, defined as albumin corrected calcium \< 2.17 mmol/L or total calcium \< 2.14 mmol/L
* Serum vitamin D (25OHD) levels \< 25 nmol/L
* estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1,73 m2
* Insufficient dental status
* Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded.
* Serum Inhibin B \< 5 pg/mL
* Androgen replacement therapy
* Hypogonadotropic hypogonadism
* BMI ≥ 35 kg/m2
What they're measuring
1
Sperm in the semen sample or TESE on day 90
Timeframe: Day 80 (semen sample) and 90 (TESE) after inclusion